This study is a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but do not otherwise meet criteria to initiate HAART for their own health. The study is designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduces morbidity and mortality compared to discontinuation and re-initiation of HAART according to current standards of care.

Morbidity and mortality [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Toxicity and side effects of medications [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Emergence of HIV resistance [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Medication adherence [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]

Quality of life [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]

Cost effectiveness and feasibility of treatment models [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Symptoms and lab values associated with clinical events [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Incidence of AIDS-defining illnesses and other select medical conditions [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Participants will continue receiving HAART after delivery or other pregnancy outcome.

Drug: Highly active antiretroviral therapy (HAART)

A combination of three or more HIV medications belonging to two or more drug classes

Active Comparator: Stop HAART

Participants will stop receiving HAART after delivery or other pregnancy outcome.

Drug: Highly active antiretroviral therapy (HAART)

A combination of three or more HIV medications belonging to two or more drug classes

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Women age > 18 years or who have attained the minimum age of independent consent, as defined by the local IRB, and are willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who are willing and able to provide written assent and whose parent or legal guardian is willing and able to provide written informed consent

Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests

Antiretroviral treatment naïve, defined as < 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy

Receipt of at least four weeks of HAART prior to study entry, at least two weeks of which must have been prior to pregnancy outcome (up to seven consecutive days of missed therapy is permitted)

CD4+ cell count ≥ 400 cells/mm3 on a specimen obtained within 120 days prior to initiation of HAART for current pregnancy

CD4+ cell count ≥ 400 cells/mm3 on a specimen obtained on HAART and within 45 days prior to study entry

The following laboratory values on a specimen obtained within 45 days prior to study entry:

Absolute neutrophil count ≥ 750/mm3

Hemoglobin ≥ 7.0 g/dL

Platelet count ≥ 50,000/mm3

AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 x ULN

Estimated creatinine clearance of ≥ 60mL/min within 45 days prior to entry using the Cockcroft-Gault formula

Intent to remain in current geographical area of residence for the duration of the study

Willingness to attend study visits as required by the study

Exclusion Criteria:

Previous participation in PROMISE (P1077)

Clinical indication for HAART including any WHO Clinical Stage 3 or 4 condition, prior or current tuberculosis disease (a positive PPD test alone is not considered exclusionary), and/or any other clinical indication per country-specific treatment guidelines

Social or other circumstances which, in the opinion of the site investigator, would hinder long-term follow up

Use of any prohibited medications within 14 days prior to study entry (refer to the study MOP for a list of prohibited medications)

Current compulsory detention (involuntary incarceration) in a correctional facility, prison, or jail for legal reasons or compulsory detention in a medical facility for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Currently breastfeeding or planning to breastfeed

Current documented conduction heart defect (specialized assessments to rule out this condition are not required; a heart murmur alone and/or type 1 second-degree atrioventricular block (also known as Mobitz I or Wenckebach) is not considered exclusionary)

Known evidence of HBV DNA levels >2000 IU/mL (approximately 10,000 copies/mL) in the presence of elevated (grade 1 and higher) ALT (HBV DNA testing is not required for study screening or enrollment but should be considered to determine whether treatment for HBV is indicated)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955968